Bureaucratic Roadblocks Threaten Biopharma Growth

Published on: 
BioPharm International, BioPharm International-06-01-2014, Volume 27, Issue 6

Protecting intellectual property rights is vital to biopharmaceutical innovation.

There is a clear link between a country’s rate of economic development and the strength of its intellectual property laws. This is particularly true in knowledge-intensive sectors such as biopharmaceuticals.

The good news is that some mature and emerging economies are making growing use of patent systems to facilitate biotechnology research and commercialization. The bad news is that a number of countries have established bureaucratic and burdensome hurdles to patentability. This reality stands to harm innovation everywhere.

Patent uncertainty abroad
The Biotechnology Industry Organization (BIO) is concerned over a series of patent revocations including a decision by India’s Supreme Court to deny patent protection for a novel therapy on the grounds it did not demonstrate enhanced efficacy. Furthermore, Brazil’s unprecedented review of patents by the health regulatory authority, China’s increased data requirements, and Canada’s increased utility requirements all ultimately undermine the drug development and patenting process and may impede the delivery of novel medicines to market.

Despite the 2010 declaration by the then-President of India that the next 10 years will be a “Decade of Innovation,” the use of a compulsory license, a series of patent revocations, and weak enforcement efforts raise serious concerns about India’s commitment to promote innovation.

The tragedy underlying this anti-intellectual property position is not simply that it diverts attention away from the real problems of access to health-care that millions of Indians face, but that it undermines the nation’s goal of becoming a healthcare and science innovator. There are companies around the world interested in collaborating in research, science, and the development of medicines in India. India’s anti-intellectual property position makes it difficult, and often impossible, for such deals to happen.

It is imperative for governments that want to foster a robust biotech innovation environment to create a set of strong intellectual property standards--particularly those governing data protection, patents, and trade secret protection--that are relevant to biological products.

Protecting IP, leveraging risk
The biotechnology industry is a dynamic, job-creating industry and presents opportunities for every country. Indeed, the vast majority of biotechnology companies are small- and medium-sized enterprises. What these companies share is a philosophy that is crucial to the task of developing biotechnology products--a willingness to take huge risks and invest private capital in development of new technologies that will lead to new products and services that will improve people’s lives.


With no source of product revenue and long development times before market launch, biopharmaceutical companies must leverage the strength of their global patent portfolio to raise the large amounts of capital required to get their innovations to the market.

Upholding the system of intellectual property rights is essential to guaranteeing future innovation and future jobs not just for US biopharmaceutical companies, but also for other countries and other industries around the world.
BIO believes that strong intellectual property laws create an environment that promotes collaboration and innovation across borders. We will continueto work around the world to champion intellectual property rights as a vital
means of creating jobs, saving lives, advancing global economic growth, and generating breakthrough solutions to global challenges.

The 2014 BIO International Convention, taking place June 23-26 in San Diego, will host an Emerging Opportunities in Global Markets Forum specifically designed to highlight biotech initiatives in global markets, looking at both emerging economies and global initiatives and trends that affect the industry’s landscape. The Forum will overview developments in key markets, cross-cutting policy trends, unique collaborations, and cross border initiatives to further innovation. To learn more, visit convention.bio.org.

About the Author
Jim Greenwood is president and CEO of the Biotechnology Industry Organization (BIO).